A Study of Brivanib (BMS-582664) in Patients With Liver Cancer and Mild, Moderate or Severe Liver Dysfunction

NCT ID: NCT00437424

Last Updated: 2011-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-06-30

Brief Summary

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The primary purpose of this protocol is to determine the effect of BMS-582664 on patients with hepatocellular carcinoma with varying levels of hepatic impairment

Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Brivanib

Intervention Type DRUG

Tablet, Oral, Brivanib 400 mg, based on Day 1 PK, QD, until progression

Interventions

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Brivanib

Tablet, Oral, Brivanib 400 mg, based on Day 1 PK, QD, until progression

Intervention Type DRUG

Other Intervention Names

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BMS-582664

Eligibility Criteria

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Inclusion Criteria

* Subjects with a biopsy proven advanced solid tumor
* Subjects with a biopsy proven diagnosis of hepatocellular carcinoma conforming to child pugh classifications A, B, or C
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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University Of Alabama At Birmingham

Birmingham, Alabama, United States

Site Status

Usc/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Case Western Reserve University

Clleveland, Ohio, United States

Site Status

South Texas Accelerated Research Therapeutics, Llc

San Antonio, Texas, United States

Site Status

Local Institution

Seville, , Spain

Site Status

Countries

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United States Spain

References

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El-Khoueiry A, Posey JA, Castillo Ferrando JR, Krishnamurthi SS, Syed S, Kollia G, Walters I, Fischer BS, Masson E. The effects of liver impairment on the pharmacokinetics of brivanib, a dual inhibitor of fibroblast growth factor receptor and vascular endothelial growth factor receptor tyrosine kinases. Cancer Chemother Pharmacol. 2013 Jul;72(1):53-64. doi: 10.1007/s00280-013-2168-z. Epub 2013 May 30.

Reference Type DERIVED
PMID: 23719718 (View on PubMed)

Related Links

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Other Identifiers

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CA182-015

Identifier Type: -

Identifier Source: org_study_id

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